FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
- Recall number
- Z-1443-04
- Recalling firm
- Boston Scientific Corporation
- Product
- Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
- Status
- Terminated
- Initiated
- 2004-08-09
- Posted
- 2004-09-14
- Terminated
- 2005-10-26
- Reason
- Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Root cause
- Other
- Action
- Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit.
- Quantity
- 48 cartons x 10 units
- Distribution
- Products sold to 53 medical facilities nationwide and one consignee in Italy.
- Lot, serial or model codes
- 6503081, 6507526
- 510(k) numbers
- ["K813462"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28